The role of the pathologist in the design and conducting of biomarker-driven clinical trials in cancer: position paper of the European Society of Pathology
Clinical trials in oncology are important tools to identify and establish new effective drugs for cancer treatment. Since the development of the concept of precision oncology, a huge number of multi-centric biomarker-driven clinical trials have been performed and promoted by either academic institutions or pharmaceutical companies. In this scenario, the role of pathologists is essential in multiple aspects, with new challenges that should be addressed. In this position paper of the European Society of Pathology, the role of pathologists as contributors to the design of the clinical trial, as local collaborators, or as members of central review laboratories is discussed. Moreover, the paper emphasizes the important role of pathologists in guiding methods and criteria of tissue biomarker testing in the biomarker-driven clinical trials. The paper also addresses issues regarding quality control, training, and the possible role of digital pathology.
Role of the pathologist in pre‑clinical studies Pre-clinical studies test drugs that might have an impact on the tumor in a number of situations. Most of the experiments are performed in cell cultures by monitoring the effects of the drug on cell viability, apoptosis, proliferation, wound healing, and other parameters, in tumor cells. 3-D cultures and patient-derived tumor organoids represent interesting tools. But frequently pre-clinical studies involve animal models, either genetically modified animals [17, 18], cell-line derived xenografts [19], and/or patient-derived xenografts in nude mice [20, 21]. The effect of the drug is assessed by the pathologic features of tumor tissue, and changes in biomarker expression, after treatment. In the case of genetically modified animals, pathologic evaluation requires veterinary pathology expertise, with previous training on the normal structure and variability of the animal tissue. In the case of patient-derived xenograft models, pathologic analysis should take the specific features of the animal
tumor microenvironment into account, which in principle differs from its human counterpart.
The paper is available here